Shock Wave Therapy Versus Low Level Laser Therapy in Patients With Plantar Fasciitis

Effect of Shock Wave Therapy Versus Low Level Laser Therapy in Patients With Plantar Fasciitis

Both shock wave therapy and low level laser therapy in plantar fasciitis are effective in improvement of such cases without any side effects but there are no previously published studies on the use of shock wave therapy versus low level laser therapy in plantar fasciitis and, hence, evidence of its acceptability and effectiveness compared with each other remains to be established.

Study Overview

• Status: Completed
• Conditions: Plantar Fascitis
• Intervention / Treatment: Other: conventional therapy; Other: shock wave therapy; Other: low level laser therapy

Detailed Description

Plantar fasciitis is a result of degenerative irritation of the plantar fascia origin at the medial calcaneal tuberosity of the heel as well as the surrounding perifascial structures, it is a common problem accounting for approximately one million patient visits per year, it is often an overuse injury. As a result tight gastrocnemius, soleus, and/or other posterior leg muscles have also been commonly found in patients with this condition.

Shock wave therapy is thought to provide long lasting analgesia and stimulate the healing process, Low level laser therapy has been used to relieve pain caused by plantar fasciitis, also stretching of the shortened and contracted plantar flexors may positively influence an individual's functional activities of daily living and decrease the risk of injury.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Reham M Lotfy, Msc; Phone Number: 01063251724; Email: mnabilbebo@gmail.com

Study Locations

• Egypt
  • Giza, Egypt
    • Reham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ranges from 40-60 years old.
2. Both genders will be included.
3. Unilateral plantar fasciitis.
4. Duration of symptoms more than 4 weeks.
5. Positive Windlass test and negative Tinel and calcaneus squeeze tests.
6. Patients will be classified according to their BMI (18.5 - 24.9) kg/m2

Exclusion Criteria:

1. Open wound, infection in plantar surface of foot.
2. History of foot surgery.
3. History of trauma or fracture in foot or ankle.
4. Neuropathic pain as diabetes mellitus.
5. Peripheral vascular disease.
6. Calcaneal stress fracture or show evidence of a foreign body or tumor of the affected heel.
7. Previously suffered a rupture or surgery of the plantar fascia. Existing or prior osteomyelitis of the involved calcaneus.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; conventional physical therapy program (Instructions, Ice application, Deep tissue massage, Stretching exercises, Joint mobilization and isometric exercises).	Other: conventional therapy; conventional therapy ( instructions, ice application, deep tissue massage, stretching exercises, joint mobilization and isometric exercises )
Experimental: Experimental group 1; Shock wave therapy + Conventional physical therapy.	Other: conventional therapy; conventional therapy ( instructions, ice application, deep tissue massage, stretching exercises, joint mobilization and isometric exercises ); Other: shock wave therapy; Acoustic waves (shock waves) that can carry energy and can propagate through tissues promote healing effects.
Experimental: Experimental group 2; Low level laser therapy + Conventional physical therapy.	Other: conventional therapy; conventional therapy ( instructions, ice application, deep tissue massage, stretching exercises, joint mobilization and isometric exercises ); Other: low level laser therapy; The application of light to a biologic system to promote tissue regeneration, reduce inflammation and relieve pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the change in pain intensity level	The visual analogue scale (VAS) is a widely utilized pain intensity level assessment instrument in patients with plantar fasciitis. The visual analogue scale (VAS) is typically composed of a horizontal line from zero (minimum value) to 10 (maximum value) where zero signifies (no pain) and 10 signifies (worst pain) one can imagine.	Before treatment and after 6 weeks treatment
Assess the change in pain pressure threshold	Pressure algometry will be used to evaluate the pain pressure threshold for the two predetermined locations on the affected leg: gastrocnemius (middle point over the muscle belly) and soleus (center point of the muscle belly 10 cm above the Achilles tendon). The participant will speak up at the point where the pressure evoke a painful sensation. This process will be repeated 3 times in the same manner, and three measurements will be recorded at the same point on the plantar fascia. An average of the three readings will be recorded. Higher algometer scores indicate greater pressure threshold, therefore less tenderness. Lower algometer scores indicate less pressure threshold, thus more tenderness.	Before treatment and after 6 weeks treatment
Assess the change in range of ankle motion	Ankle range of motion (ROM) will be measured by using digital goniometer (ankle dorsiflexion and plantarflexion ranges will be measured). It can monitor the progress of intervention.	Before treatment and after 6 weeks treatment
Assess the change in foot functional disability	Foot functional disability will be assessed by foot and ankle ability measure questionnaire (FAAM). Higher scores on the questionnaire indicate a higher level of physical functioning and lower scores on the questionnaire indicate a lower level of physical functioning.	Before treatment and after 6 weeks treatment
Assess the change in ankle stability	The Human Assessment Computer (HUMAC) Balance System will be used in the current study to assess limits of stability of ankle joint.	Before treatment and after 6 weeks treatment

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Fatma S Amin, Professor, Cairo University; Study Director: Rania N Karkousha, Ass.prof, Cairo University; Study Director: Mohamed I Abd Elhay, Lecturer, Cairo University; Study Director: Ashraf N Moharram, Professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): October 10, 2023
• Study Completion (Actual): October 10, 2023

Study Registration Dates

• First Submitted: April 29, 2023
• First Submitted That Met QC Criteria: May 10, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: low level laser therapy; shock wave therapy; stretching exercises
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: P.T.REC/012/004154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No